Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study (PROTECT-07)

January 29, 2026 updated by: Centre Paul Strauss
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Colmar, France, 68024
        • Not yet recruiting
        • Hôpitaux civils de Colmar
        • Principal Investigator:
          • Jean-Marc LIMACHER, MD
        • Contact:
          • Manon VOEGELIN
      • Strasbourg, France, 67033
        • Recruiting
        • Institut de cancérologie Strasbourg Europe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Woman ≥ 18 years old
  • Stage I to III breast cancer
  • Patient currently planning (neo)adjuvant treatment combining anthracycline-cyclophosphamide and weekly paclitaxel (± trastuzumab)
  • Affiliation to a social security system
  • Able to speak, read and understand French

Exclusion Criteria:

  • No prior chemotherapy treatment
  • Any known cardiac or vascular pathology
  • Contraindications to physical fitness assessment
  • Protected adult
  • Psychiatric, musculoskeletal or neurological problems
  • Pregnant or breastfeeding woman (NB: this population is already subject to a contraindication to (neo)adjuvant treatment. For women of childbearing age, a betaHCG dosage is already carried out systematically before the start of chemotherapy and information on the need for contraception throughout the chemotherapy period is provided before the start of treatment. As part of this study, only the presence of this test with a negative result at the start of chemotherapy will be checked. inclusion, if available).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training group
This group of patients will perform concentric cycling training program during the chemotherapy treatment.
Procedure: Training sessions
The training program will be performed during 15 weeks, with one session per week.
No Intervention: Control group
This group of patients will benefit from standard care without additional training program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall exercise capacity
Time Frame: At week 18 (the end of chemotherapy treatment)
To investigate the superiority of a concentric pedaling training program during (neo)adjuvant chemotherapy versus the absence of a training program in patients with early breast cancer. The overall exercise capacity is assessed by the 6-minute walk test (TDM6) between the two groups.
At week 18 (the end of chemotherapy treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Physiological variables associated with exercise capacity - cardiorespiratory capacity
Time Frame: At weeks 8.
To examine the effects of the training program on VO2max.
At weeks 8.
Physiological variables associated with exercise capacity - cardiorespiratory capacity
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on VO2max.
At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle function
Time Frame: At weeks 8.
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
At weeks 8.
Physiological variables associated with exercise capacity - muscle function
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on maximal aerobic power determined as the lowest exercise intensity inducing a plateauing of O2 consumption during a maximum exercise test.
At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - body composition
Time Frame: At weeks 8.
To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.
At weeks 8.
Physiological variables associated with exercise capacity - body composition
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on lean mass, fat mass, muscle mass assessed by bioimpedancemetry.
At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At weeks 8.
To examine the effects of the training program on muscle thickness assessed by ultrasonography.
At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At weeks 8.
To examine the effects of the training program on fascicle length assessed by ultrasonography.
At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At weeks 8.
To examine the effects of the training program on cross-sectional area assessed by ultrasonography.
At weeks 8.
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on muscle thickness assessed by ultrasonography.
At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on fascicle length assessed by ultrasonography.
At week 18 (the end of chemotherapy treatment)
Physiological variables associated with exercise capacity - muscle architecture
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program on cross-sectional area assessed by ultrasonography.
At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - quality of life
Time Frame: At weeks 8.
To examine the effects of the training program with the FACT-G questionnaire
At weeks 8.
Psychosocial variables associated with exercise capacity - quality of life
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program with the FACT-G questionnaire
At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - fatigue
Time Frame: At weeks 8.
To examine the effects of the training program with the FACIT-F questionnaire
At weeks 8.
Psychosocial variables associated with exercise capacity - fatigue
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program with the FACIT-F questionnaire
At week 18 (the end of chemotherapy treatment)
Psychosocial variables associated with exercise capacity - appetite level
Time Frame: At weeks 8.
To examine the effects of the training program with the FAACT questionnaire
At weeks 8.
Psychosocial variables associated with exercise capacity - appetite level
Time Frame: At week 18 (the end of chemotherapy treatment)
To examine the effects of the training program with the FAACT questionnaire
At week 18 (the end of chemotherapy treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Paul Strauss

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BENDER Laura, MD, Institut de cancérologie Strasbourg Europe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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